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Patent 2305189 Summary

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(12) Patent: (11) CA 2305189
(54) English Title: SYSTEM FOR MONITORING AND TREATING SLEEP DISORDERS USING A TRANSTRACHEAL CATHETER
(54) French Title: SYSTEME DE CONTROLE ET DE TRAITEMENT DE TROUBLES DU SOMMEIL AU MOYEN D'UN CATHETER TRANSTRACHEAL
Status: Deemed expired
Bibliographic Data
(51) International Patent Classification (IPC):
  • A61M 16/00 (2006.01)
  • A61M 16/04 (2006.01)
  • A62B 7/00 (2006.01)
  • F16K 1/08 (2006.01)
  • A61B 5/00 (2006.01)
  • A61B 5/083 (2006.01)
  • A61B 5/087 (2006.01)
  • A61M 16/12 (2006.01)
(72) Inventors :
  • CHRISTOPHER, KENT L. (United States of America)
(73) Owners :
  • CS MEDICAL, INC. (United States of America)
(71) Applicants :
  • CHRISTOPHER, KENT L. (United States of America)
(74) Agent: BORDEN LADNER GERVAIS LLP
(74) Associate agent:
(45) Issued: 2006-02-21
(86) PCT Filing Date: 1998-10-15
(87) Open to Public Inspection: 1999-04-29
Examination requested: 2000-05-17
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/US1998/021689
(87) International Publication Number: WO1999/020332
(85) National Entry: 2000-04-04

(30) Application Priority Data:
Application No. Country/Territory Date
08/954,673 United States of America 1997-10-20

Abstracts

English Abstract



An apparatus for augmenting ventilation of a patient (100) and
monitoring the patient's breathing patterns uses a transtracheal catheter
(10). A substantially constant flow of oxygen/air is supplied through
one of the lumens (12) of the transtracheal catheter (10) into the
patient's tranchea (101) to augment the patient's spontaeous breathing.
A respiration sensor (80, 82, 85 or 87) measures a predetermined
physical property (e.g., pressure or flow rate) related to the patient's
respiration at the distal end (17) of the transtracheal catheter (10). This
data is recorded to monitor the patient's respiration patterns over time
for subsequent analysis. The respiration data can be recorded on a strip
chart or stored in digital form for transmission by modem or removable
data storage media to a remote facility for analysis. A capnometer
(87) can be connected to one of the transtracheal catheter lumens (16)
to measure the carbon dioxide concentration of the air exhaled by the
patient (100). The distal end of the transtracheal catheter (10) can also
be equipped with an oximetry probe (85) that contacts the lining of
the patient's trachea (101) to measure blood oxygen saturation. The
oximetry data is recorded concurrently with the respiration data and
used for diagnosis and monitoring of sleep disorders, such as sleep
apnea and hypopnea.


French Abstract

L'invention concerne un appareil destiné à augmenter la ventilation d'un patient (100) et à contrôler le mode de respiration du patient au moyen d'un cathéter transtrachéal (10). Un flux sensiblement constant d'oxygène/air est introduit par une des lumières (12) du cathéter transtrachéal (10) dans la trachée (101) du patient, pour augmenter la respiration spontanée du patient. Un détecteur de respiration (80, 82, 85 ou 87) mesure une propriété physique prédéterminée (par exemple la pression ou le débit) associée à la respiration du patient à l'extrémité distale (17) du cathéter transtrachéal (10). Ces données sont enregistrées pour contrôler le mode de respiration du patient de manière prolongée pour une analyse ultérieure. Les données de respiration peuvent être enregistrées sur un diagramme à déroulement continu ou mémorisées sous forme numérique pour être transmises par un modem ou un support de mémorisation de données amovible à une installation à distance pour être analysées. Un capnomètre (87) peut être connecté à une des lumières (16) du cathéter transtrachéal pour mesurer la concentration de dioxyde de carbone dans l'air rejeté par le patient (100). L'extrémité distale du cathéter transtrachéal (10) peut également être équipé d'une sonde d'oxymétrie (85) qui entre en contact avec la muqueuse de la trachée (101) du patient pour mesurer la saturation du sang en oxygène. Les données d'oxymétrie sont enregistrées conjointement avec les données de respiration et sont utilisées pour diagnostiquer et contrôler des troubles du sommeil tels que l'apnée et l'hypopnée du sommeil.

Claims

Note: Claims are shown in the official language in which they were submitted.



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I CLAIM:

1. An apparatus for augmenting ventilation of a
spontaneously breathing patient and monitoring the patient's
breathing patterns, said apparatus comprising:
a transtracheal catheter having at least one lumen with a distal
port inserted into the patient's trachea;
a source for supplying a controlled flow of
oxygen/air through said transtracheal catheter into the patient's
trachea to augment the patient's spontaneous breathing;
respiration sensor means for measuring a predetermined
physical property related to the patient's tracheal respiration; and
recording means for recording data from said respiration
sensor means to monitor the patient's spontaneous respiration
patterns over time while the patient is asleep for diagnosis of sleep
disorders.
2. The apparatus of claim 1 wherein said transtracheal catheter
further comprises a second lumen extending into the patient's
trachea, and wherein said respiration sensor means comprises a
pressure transducer measuring tracheal air pressure through said
second lumen.
3. The apparatus of claim 2 wherein said second lumen further
comprises a distal port located a predetermined distance above the
distal port of said first lumen of said transtracheal catheter.
4. The apparatus of claim 3 wherein said distal port of said
second lumen is located anterior to said distal port of said first lumen.




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5. The apparatus of claim 1 wherein said respiration sensor
means comprises a pressure transducer located on said transtracheal
catheter within said trachea for measuring tracheal air pressure.

6. The apparatus of claim 1 wherein said respiration sensor
means comprises a flow sensor.

7. The apparatus of claim 1 further comprising processor means
for analyzing said recorded data to identify episodes of disordered
breathing.

8. The apparatus of claim 7 wherein said respiration sensor
means comprises a pressure transducer and wherein said processor
means identifies episodes of obstructive sleep apnea and hypopnea
by periods of increasing pressure within the patient's trachea.

9. The apparatus of claim 7 wherein said respiration sensor
means comprises a pressure transducer and wherein said processor
means identifies episodes of unobstructed central sleep apnea by
periods without sinusoidal pressure swings within the patient's
trachea.

10. The apparatus of claim 7 wherein said respiration sensor
means comprises a flow sensor and wherein said processor means
identifies episodes of sleep apnea and hypopnea by periods of
abnormal airflow within the patient's trachea.

11. The apparatus of claim 1 wherein said recording means
comprises a strip chart recorder.





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12. The apparatus of claim 1 wherein said recording means
comprises a computer with data storage means.

13. The apparatus of claim 1 further comprising means for
transmitting said recorded data to a remote location for analysis.

14. The apparatus of claim 13 wherein said means for transmitting
recorded data comprises removable data storage media.

15. The apparatus of claim 13 wherein said means for transmitting
recorded data comprises a modem.

16. The apparatus of claim 1 further comprising an oximeter
connected to said recording means for monitoring the blood oxygen
level of the patient.

17. The apparatus of claim 16 wherein said oximeter further
comprises an oximeter probe located on a distal, posterior portion of
said transtracheal catheter to contact the lining of the patient's
trachea.

18. The apparatus of claim 1 further comprising a capnometer
connected to said recording means for monitoring the carbon dioxide
level in the patient's trachea.

19. An apparatus for augmenting ventilation of a
spontaneously breathing patient and monitoring the patient's
spontaneous breathing patterns, said apparatus comprising:
a transtracheal catheter having:
(a) a first lumen having a distal port inserted into the
patient's trachea; and




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(b) a second lumen extending into the patient's trachea;
a source for supplying a controlled flow of
oxygen/air through said first lumen of said transtracheal catheter into
the patient's trachea to augment the patient's spontaneous breathing;
a pressure sensor measuring tracheal air pressure through
said second lumen of said transtracheal catheter; and
recording means for recording data from said pressure sensor
over a period of time to monitor the patient's spontaneous respiration
patterns while the patient is asleep for diagnosis of sleep disorders.

20. The apparatus of claim 19 wherein said second lumen further
comprises a distal port located a predetermined distance above the
distal port of said first lumen of said transtracheal catheter.

21. The apparatus of claim 20 wherein said distal port of said
second lumen is located anterior to said distal port of said first lumen.

22. The apparatus of claim 19 further comprising a flow sensor
connected to said recording means for measuring tracheal air flow.

23. The apparatus of claim 22 further comprising processor means
for analyzing said recorded data to identify episodes of disordered
breathing.

24. The apparatus of claim 23 wherein said processor means
identifies episodes of obstructive sleep apnea and hypopnea by
periods of increasing pressure within the patient's trachea.

25. The apparatus of claim 23 wherein said processor means
identifies episodes of unobstructed central sleep apnea by periods
without sinusoidal pressure swings within the patient's trachea.





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26. The apparatus of claim 19 wherein said recording means
comprises a computer with data storage means.

27. The apparatus of claim 19 further comprising an oximeter
connected to said recording means for monitoring the blood oxygen
level of the patient.

28. The apparatus of claim 27 wherein said oximeter further
comprises an oximeter probe attached to a distal, posterior portion of
said transtracheal catheter to contact the lining of the patient's
trachea.

29. The apparatus of claim 19 further comprising a capnometer
connected to said recording means for monitoring the carbon dioxide
level in the patient's trachea.


Description

Note: Descriptions are shown in the official language in which they were submitted.



CA 02305189 2000-04-04
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SYSTEM FOR MONITORING AND TREATING SLEEP DISORDERS
USING A TRANSTRACHEAL CATHETER
BACKGROUND OF THE INVENTION
1. Field of the i vention. The present invention relates
generally to the field of systems for diagnosing, treating, and
monitoring sleep disorders. More specifically, the present invention
discloses a system for monitoring and treating sleep disorders, such
as sleep apnea and hypopnea, using a transtracheal catheter.
2. Statement of the Problem. The conventional approach to
diagnosis of sleep disorders has been to require the patient to
participate in a "sleep study". The patient is outfitted with an array of
sensors attached to the surface of the body to monitor the patient's
respiration, pulse, and blood oxygen saturation. A strip chart recorder
traces the sensor signals on paper for later analysis by a health care
professional.
Conventional sleep studies have several shortcomings. The
complexity and expense of the required equipment dictate that sleep
studies are usually conducted in a clinic setting, i.e., a hospital or
sleep laboratory. This significantly increases the costs involved. In
addition, the patient often finds it difficult to sleep in a strange setting,
particularly while wearing sensors tethered by wires to a strip chart
recorder. Respiration is typically measured by requiring the patient to
wear sensor devices applied to the face and body, which is especially
uncomfortable to wear while trying to sleep.

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With newer technology, sleep studies can be done in the home,
but this still involves attaching various sensor devices and wires to the
body surface. These tests are usually single night events, and are too
complex and expensive to be practical in monitoring treatment
efficacy and patient compliance over extended periods of time, such
as days, weeks, or months.
The most common treatment of sleep apnea involves the
uncomfortable sensation of blowing air under pressure into the upper
airway via a mask strapped to the face. Continuous positive airway
pressure (CPAP) and bi-level positive airway pressure (BiPAP) are
the treatment modalities that have been delivered by masks. Even
though sleep apnea is often corrected with CPAP and BiPAP, both
have excessively high non-compliance rates due to patient discomfort.
Therefore, a clear need exists for a respiration monitoring
system for diagnosis of sleep disorders that is suitable for use outside
of clinical settings, and minimizes patient discomfort. This system has
even greater value if administered in conjunction with transtracheal
augmentation of ventilation, which offers greater efficacy, comfort, and
compliance over existing technology, such as BiPAP and CPAP.
3. Pr'or The prior art relevant to the present invention falls
into several different categories:
Transtracheal Catheters. Transtracheal catheters have been
used for several years to deliver a flow of air/oxygen into the patient's
trachea and lungs to supplement the patient's spontaneous
respiration. Transtracheal oxygen therapy is commonly used to
support patients with compromised respiratory systems, such as
resulting from emphysema or chronic obstructive respiratory disease
(COPD), and pulmonary fibrosis.


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Spofford et al. (U.S. Patent Nos. 5,186,168 and 5,090,408}
disclose a system for continuously supplying supplemental oxygen to
a patient through a transtracheal catheter at relatively low pressures
and relatively low flow rates.
Christopher (U.S. Patent Nos. 5,279,288 and 5,419,314)
discloses a system for augmenting ventilation of a spontaneously-
breathing patient using a transtracheal catheter. A high continuous
flow of humidified air/oxygen is supplied through a transtracheal
catheter into the patient's trachea and lungs. Clinical experience
indicates that transtracheal augmentation of ventilation is efficacious
and more comfortable than previous technology using BiPAP or
CPAP. Compliance appears to improve as well. Christopher
mentions that the system can be used to treat sleep apnea. The
increased tracheal pressure produced by the high flow of airloxygen
helps to keep the patient's upper airway open and thereby reduces
the frequency and severity of episodes of sleep apnea and hypopnea.
Leger et al. (French Patent No. 2594034) discloses a first
embodiment of a transtracheal catheter with a single lumen in figures
1-3. A gate mechanism 6 measures the back pressure through the
catheter and uses this information to control the flow rate 13 to match
the patient's inspiration as shown in figures 4 and 5. The second
embodiment shown in cross-section in figure 8 has two lumens. The
second lumen 23 carries a low flow of oxygen at a pressure slightly
higher than atmospheric pressure, as shown by the dashed line P23
in figure 9. The back pressure, PM, measured through the second
lumen is used to control the flow rate 13 through the gate mechanism
6 as shown in figures 9 and 10. In particular, the gate 6 opens
whenever PM passes downward through P23 (indicating the start of
inspiration), and closes whenever PM passes upward through P23.


CA 02305189 2000-04-04
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Pressure Sensors. The prior art also includes a wide variety
of systems for monitoring respiration or detecting sleep apnea using
pressure transducers. For example:
Sander et al. (U.S. Patent No. 5,148,802} disclose a system for
maintaining airway patency to treat sleep apnea by alternating high
and low level positive airway pressure through a face mask. The high
and low airway pressure are coordinated with the patient's
spontaneous respiration. This is an example of a BiPAP system.
Fry (U.S. Patent No. 4,459,982) discloses servo-controlled
demand regulator for a respiratory ventilator. Gas is supplied through
an endotracheal tube 34 to coincide with the patient's respiratory
pattern as monitored by a pressure transducer.
Brady et al. (U.S. Patent No. 5,385,142) discloses an apnea-
sensitive ventilator that measures both pressure and flow.
Essen-Moller (U.S. Patent No. 5,477,8fi0) discloses a multi-
lumen catheter for measuring respiration using an external pressure
transducer connected to one of the lumens. The patient's respiration
is monitored and recorded.
Sackner (U.S. Patent Nos. 4,648,407 and 4,860,766) discloses
a method for monitoring intrapleurai pressure in newborns. The
system includes a pressure transducer connected to a strip chart
recorder, and a thermistor placed under the patient's nostrils for
measuring flow.
Bacaner et al. (U.S. Patent No. 4,966,141) and Broadhurst et
al. (U.S. Patent No. 5,043,576) disclose an endotracheal tube that
can also be used for mass spectrometry. The endotracheal tube has
multiple lumens for measuring pressure and flow rate, and for gas
sampling.
Bombeck (U.S. Patent No. 4,981,470) discloses an
intraesophageal catheter with a pH sensor. The catheter also
includes a pressure sensor for monitoring sleep apnea.


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Pfohl (U.S. Patent No. 4,981,139) discloses a system for
monitoring vital signs that includes an esophageal stethoscope 14
with a pressure transducer.
Flow Sensors. The prior art includes a number of references
that employ a thermistor or other flow sensor for measuring the
patient's breathing rate or flow rate, e.g., Bacaner et al. (U.S. Patent
No. 4,966,141 ), Broadhurst et al. (U.S. Patent No. 4,850,371 ), and
Sackner (U.S. Patent Nos. 4,648,407 and 4,860,766). However, none
of these involve a transtracheal catheter.
Wilkinson (U.S. Patent No. 5,413,111 ) and Stasz (U.S. Patent
No. 5,311,875} cover breathing sensors for diagnosing sleep apnea
that are placed under the nostrils.
Wittmaier et a1. (U.S. Patent No. 4,366,821 ) disclose a
breathing monitor having an endotracheal tube with a thermistor 14
(figure 2} to measure the patient's breathing rate.
Oximeters. The prior art includes many references that
disclose general examples of optical oximetry, such as Mendelson et
al. (U.S. Patent No. 5,277,181 ), Fatt (U.S. Patent No. 3,893,444),
Shaw et al. (U.S. Patent Nos. 3,847,483, 4,114,604, and 4,416,285},
Sperinde (U.S. Patent No. 4,623,248), and Sperinde et al. (U.S.
Patent No. 4,453,218). Several of the prior art references combine
various types of catheters with an oximeter, e.g., Robinson et al. (U.S.
Patent No. 5,494,032), Johnson (U.S. Patent No. 3,866,599), and
Moran et al. (U.S. Patent No. 4,776,340). Buchanan {U.S. Patent No.
5,005,573) shows an endotracheal tube with an oximeter. Brain (U.S.
Patent No. 5,282,464) discloses a reflectance oximeter 23 mounted
on the upstream side of a laryngeal mask to face the posterior wall of
the pharynx.


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4. Solution to the Problem. None of the prior art . references
discussed above show a system for both monitoring patient
respiration patterns and supplying a supplemental continuous flow of
air/oxygen through a transtracheal catheter for diagnosis, treatment,
and monitoring of sleep disorders, such as sleep apnea. In particular,
none of the prior art references discussed above show the
combination of a multi-lumen transtracheal catheter, a pressure
transducer, and means for recording the patient's breathing patterns
over time. The transtracheal catheter in the present system can also
be equipped with a flow sensor, oximeter, or capnometer to generate
more complete data for diagnosis.
The present system overcomes a number of disadvantages
associated with conventional sleep studies by eliminating the need for
external sensors attached to the body and permitting data to be
gathered conveniently while the patient remains at home. In addition,
the present system can be readily installed as an add-on to
conventional transtracheal augmented ventilation therapy. In this
configuration, the system can be used to record respiration data for
an initial diagnosis, and subsequently used on an ongoing basis for
monitor the effectiveness of transtracheal augmented ventilation
therapy in treating sleep disorders, such as obstructive sleep apnea
and hypopnea.


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_7_
This invention provides an apparatus for augmenting ventilation
of a patient and monitoring the patient's breathing patterns using a
transtracheal catheter. A substantially constant flow of oxygen/air is
supplied through one of the lumens of the transtracheal catheter into
the patient's trachea to augment the patient's spontaneous breathing.
A respiration sensor measures a predetermined physical property
(e.g., pressure or flow) related to the patient's respiration at the distal
end of the transtracheal catheter. This data is recorded to monitor the
patient's respiration patterns over time for subsequent analysis. The
respiration data can be recorded on a strip chart or stored in digital
form for transmission by modem or removable data storage media to
a remote facility for analysis. A capnometer can be connected to one
of the transtracheal catheter lumens to measure the carbon dioxide
concentration of the air exhaled by the patient. The distal end of the
transtracheal catheter can also be equipped with an oximetry probe
that contacts the lining of the patient's trachea to measure blood
oxygen saturation. The oximetry data is recorded concurrently with
the respiration data and used for diagnosis of sleep disorders, such
as sleep apnea and hypopnea.
A primary object of the present invention is to provide a system
for monitoring and recording respiration data while supplying a
supplemental flow of air/oxygen to the patient's lungs.
Another object of the present invention is to provide a system
recording respiration data that can be readily used outside of clinical
settings.
Yet another object of the present invention is to provide a
system that can be readily added to conventional transtracheal


CA 02305189 2000-04-04
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_$_
augmented ventilation therapy for diagnosing, treating, and monitoring
sleep disorders.
These and other advantages, features, and objects of the
present invention will be more readily understood in view of the
following detailed description and the drawings.


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_g_
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention can be more readily understood in
conjunction with the accompanying drawings, in which:
FIG. 1 is a simplified block diagram of the present invention.
FIG. 2 is a simplified block diagram of an embodiment of the
present invention in which a number of patient monitoring units 200
transmit stored data to a central facility 300 for analysis and review.
FIG. 3 is a cross-sectional view of a multi-lumen transtracheal
catheter 10.
FIG. 4 is another cross-sectional view of the multi-lumen
transtracheal catheter 10.
FIG. 5 is a side view of the transtracheal catheter 10 inserted
into the patient's trachea 101. A portion of the trachea 101 is shown
in cross-section.
FIG. 6 is a cross-sectional view of an alternative embodiment
of the transtracheal catheter 10 having a respiration sensor 80, 82 at
the distal end of the secondary lumen 16.
FIG. 7 is a cross-sectional view of yet another alternative
embodiment of the transtracheal catheter 10 having a pulse oximeter
85 on the posterior side of the distal end of the transtracheal catheter.
FIG. 8 is a graph showing tracheal pressure, air flow, chest wall
movement, blood oxygen saturation, and carbon dioxide
measurement as functions of time for a patient experiencing an
episode of obstructive hypopnea.
FIG. 9 is a graph showing tracheal pressure, air flow, chest wall
movement, blood oxygen saturation, and carbon dioxide
measurement as functions of time for a patient experiencing an
episode of obstructive apnea.


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-10-
FIG. 10 is a graph showing tracheal pressure, air flow, chest
wall movement, blood oxygen saturation, and carbon dioxide
measurement as functions of time for a patient experiencing an
episode of central apnea.


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DETAILED DESCRIPTION OF THE INVENTION
FIG. 1 is a simplified block diagram of the patient monitoring
unit 200. The patient monitoring unit 200 serves both to supply
air/oxygen through the transtracheal catheter 10 to the patient 100,
and to store data from one or more sensors 80, 82, 85, and 87
monitoring the patient's respiration, blood oxygen saturation, and
pulse.
Air is provided by a compressor 40 and blended with oxygen
from an external source in a mixing chamber 30. A flow sensor and
oxygen analyzer 50 monitor the flow rate and oxygen content of the
airloxygen supplied to the transtracheal catheter 10. A humidifier 70
adds humidity to the airloxygen and a temperature probe 71 monitors
its temperature. A purge pump 72 can be used to periodically purge
accumulated condensation and respiratory secretions from the lines
and the transtracheal catheter 10 lumens.
Overall operation of the patient monitoring unit 200 is controlled
by a computer processor 60 having a conventional display and control
panel 62. The processor receives respiration data from one or more
respiration sensors (e.g., a pressure transducer 80, airflow sensor 82,
pulse oximetry probe 85, and/or capnometer 87). This respiration
data is recorded or stored by a data storage / recorder unit 61 for later
review. For example, respiration data can recorded using a strip chart
recorder or stored in machine-readable form on magnetic disk,
magnetic tape, floppy diskettes, or other data storage media. In the
preferred embodiment, the patient monitoring unit 200 also includes
means for communicating data with other computers (e.g., modem
63, RS-232 port 64, or removable data storage media).
FIGS. 3 and 4 provide cross-sectional views of the multi-lumen
transtracheal catheter 10. FIG. 5 illustrates the transtracheal catheter


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after it has been inserted through an incision into the patient's trachea
101. The first lumen 12 delivers a substantially constant flow of
airloxygen from the patient monitoring unit 200 into the patient's
trachea 101. In the embodiment illustrated in FIGS. 3 through 5, the
transtracheal catheter 10 has a second lumen 16 used to measuring
tracheal respiration.
The second lumen 16 typically extends along the underside of
the first lumen 12. Its distal portion extends into the patient's trachea
101 through the same incision as the first lumen 12. During insertion
of the transtracheal catheter 10, the first lumen 12 contacts the
posterior wall of the trachea 101 and curves downward as shown in
FIG. 5. This results in the distal portion of the second lumen 16 being
anterior to the first lumen 12, thereby maintaining a separation
between the second lumen 16 and the trachea wall. This helps to
prevent the second lumen 12 from becoming obstructed by mucous.
In addition, the distal port 17 of the second lumen 16 is located a
short distance above the distal port 13 of the first lumen 12, which
helps to isolate the respiratory readings taken through the second
lumen 16 from local effects associated with the flow of airloxygen
exiting the first lumen 12. Alternatively, the second lumen 16 can be
equipped with a series of small side ports extending through the wall
of the distal portion of the second lumen 16 to more accurately
measure average respiratory readings within the trachea 101.
Both the first and second lumens 12, 16 are equipped with
standardized connectors 11, 15 at their proximal ends to simplify
hook-up to the patient monitoring unit 200. A collar or flange 18
extends outward from the transtracheal catheter at a predetermined
position along its length. The collar 18 sets a predetermined
maximum depth for insertion of the distal portion of the transtracheai
catheter 10 into the patient's trachea 101. The collar 18 can also be


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connected to a neck bracelet to hold the transtracheal catheter 10 in
place on the patient's neck.
The respiration sensor can be place in any of a number of
possible locations. For example, the embodiment illustrated in FIG. 1
employs a pressure transducer 80 housed within the patient
monitoring unit 200. The pressure transducer 80 is connected to the
proximal end 15 of the second lumen 16 of the transtracheal catheter
to measure tracheal pressure.
In contrast, FIG. 6 is a cross-sectional view of an alternative
10 embodiment of the transtracheal catheter 10, in which the pressure
transducer 80 has been attached to the distal end of the transtracheal
catheter 10. The lead wires 81 connecting the pressure transducer
80 extend through the second lumen 16 to the patient monitoring unit
200. Preferably, the pressure transducer 80 is located on the anterior
side of the catheter 10 so that it is not in contact with the wall of the
trachea and can therefore accurately measure tracheal pressure.
Additionally, the pressure transducer 80 should be positioned above
the distal port 13 of the first lumen 12 so that its pressure readings are
relatively unaffected by the air flow delivered by the first lumen 12.
An airflow sensor 82 can be used as a respiration sensor,
either alone or in combination with a pressure transducer 80. For
example, the airflow sensor can be housed within the patient
monitoring unit 200 and connected to the second lumen 16 of the
transtracheal catheter 10 to measure tracheal airflow. Alternatively,
the airflow sensor 82 can be mounted on the anterior distal portion of
the catheter 10 as illustrated in FIG. 6. A thermistor can be employed
as the respiration sensor 82.
FIG. 7 is a cross-sectional view of another embodiment of the
transtracheal catheter 10, in which a pulse oximeter probe 85 is
mounted on the distal, posterior portion of the catheter 10. This
causes the oximeter probe 85 to come into intimate contact with the


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mucosal lining of the trachea wall. In one embodiment, the oximeter
probe 85 consists of a pair of light emitting diodes (LEDs) that
transmit light at two selected wavelengths into the trachea wall. Two
photodetectors generate voltages indicative of the relative absorption
of the two wavelengths by the surrounding tissue and blood in the
trachea wall. These voltages are communicated by lead wires and a
connector 86 to an external calibration unit housed within the patient
monitoring unit 200, which calculates blood oxygen saturation and
pulse. Alternatively, the oximeter probe 85 can be made of two
optical fibers. The first optical fiber carries two wavelengths of light
from external sources and transmits the light into the trachea wall.
The second optical fiber picks up a portion of the light reflected by the
adjacent tissue and blood and returns it to an external set of
photodetectors and a calibration unit contained within the patient
monitoring unit 200. The resulting blood oxygen saturation and pulse
data output by the calibration unit are recorded along with the
pressure and flow data by the patient monitoring unit 200 for later
analysis.
The present system 200 can also be equipped with a
capnometer 87 to measure the carbon dioxide concentration of air
exhaled by the patient. In the preferred embodiment, the capnometer
87 is connected to the second lumen 1 fi of the transtracheal catheter
10 to sample air from within the patient's trachea. The capnometer 87
draws air samples by aspiration. This can be done on a continual
basis if the second lumen is not shared with the respiration sensor
(i.e., pressure transducer 80 or flow sensor 82). Otherwise, a
solenoid valve can be employed to alternately connect the second
lumen to the respiration sensor and to the capnometer 87. Operation
of the valve should be synchronized by the processor 60 to be in
phase with the patient's respiration. For example, tracheal C02
should be measured during expiration.


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Alternatively, the transtracheal catheter 10 could include a third
lumen used solely for the capnometer 87. If the size of carbon
dioxide sensors is substantially reduced in the future, it may become
possible to mount the sensor 87 on the distal portion of the
transtracheal catheter 16 as illustrated in FIG. 6.
Conventional capnography systems measure carbon dioxide
concentration as air is exhaled through the nose or mouth. This
approach has a number of shortcomings. The carbon dioxide content
of air in the patient's mouth, nose, and upper airway at the beginning
of expiration has little relationship to the patient's arterial carbon
dioxide level. The carbon dioxide content of the gas in the patient's
alveoli and bronchial tubes provides the closest approximation of
arterial carbon dioxide concentration due to the active exchange of
gases across the walls of the alveoli and bronchi. Above the alveoli
and bronchial tubes, there is little exchange of gases with the patient's
bloodstream. These portions of the anatomy hold a significant volume
of gas and allow a significant opportunity for alveolar gas to mix with
other gases. Thus, the gas exiting the mouth or nose during the initial
phase of each exhalation provides a relatively inaccurate
measurement of C02. It is only during the end phase of each
exhalation that gas from the alveoli and bronchi reaches the mouth
and nose to provide a more accurate COZ measurement. This is
commonly referred to as the end-tidal C02 measurement. However,
with conventional capnography systems, the accuracy of this end-tidal
C02 measurement is compromised by the mixing of gases in the
upper airway.
One conventional alternative for measuring carbon dioxide
involves periodic arterial blood gas samples. This is expensive,
painful, and cannot be used to measure carbon dioxide
concentrations on a continuous basis, unlike the present system.
Another conventional alternative monitors blood oxygen and carbon


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dioxide levels by measuring the relative transcutaneous adsorption of
light at two wavelengths. This approach works reasonably well with
infants, but is less accurate with adults due to greater variations in
skin condition and pigmentation.
In contrast to these prior art approaches, the present system
provides a more direct means for continuously measuring end-tidal
carbon dioxide. The distal end of the transtracheal catheter 10 is
typically located above the caring following insertion. This enables
the capnometer 87 to draw samples from a location relatively close to
the bronchial tubes and therefore increases accuracy.
Many patients with COPD tend to under-breathe or
hypoventilate, resulting in elevated COZ levels. The capnometer 87
can be used for diagnosis by documenting end-tidal COZ levels.
However, capnography can also be used to document the
effectiveness of transtracheal augmented ventilation therapy or to
optimize the flow rate and oxygen content of gas supplied through the
transtracheal catheter 10.
FIG. 2 illustrates an embodiment of the present invention in
which a central facility 300 receives data from a number of remote
patient monitoring units 200. The central facility can be configured to
facilitate manual review of the data by a health care provider,
automated review of the data by a computer processor 360, or the
processor 360 can be used to identify periods of disordered breathing
patterns in the data for review by the health care professional.
The central facility 300 includes a computer processor 360
equipped with a displaylcontrol panel 362, and data storage/recorder
361. The central facility 300 can be linked by the patient monitoring
units 200 using modems 363 and a telephone line. Alternatively, a
local area network (LAN), wide area network (WAN), or Internet
access could be employed for transmission of data to the central
facility 300. Removable data storage media 365 (e.g., diskette,


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removably hard disk, or magnetic tape) can be transported from each
patient monitoring unit 200 to the central facility 300 for
communicating data for analysis.
FIGS. 8 through 10 are graphs illustrating disordered breathing
patterns associated with obstructive hypopnea, obstructive apnea,
and central apnea, respectively. These graphs include strain gauge
measurement of chest wall movement, which is standard technology
for the study of respiration during sleep recordings. The graphs also
depict measurement of tracheal pressure, tracheal airflow, oxygen
saturation, and tracheal carbon dioxide level, as would be based on
the present invention.
In FIG. 8, obstructive hypopnea is indicated by the moderately
increased amplitude of the sinusoidal tracheal pressure curve.
Tracheal air flow also follows a generally sinusoidal curve with a
moderately decreased amplitude. This is consistent with shallow
breathing, but not complete obstruction of the patient's airway. Blood
oxygen saturation decreases with the obstructive hypopneas and
improves when the obstructive hypopneas resolve. The tracheal
carbon dioxide level follows a generally sinusoid curve with
respiration. The minimum for each respiration cycle occurs during
inspiration and reflects the essentially constant C02 content of
ambient air. The maximum for each respiration cycle occurs during
expiration as C02 is removed from the lungs. During normal
respiration, the maximum COZ value for each respiration cycle
changes very little for a given level of exertion by the patient.
However, during obstructive hypopnea, the upper airway is partially
obstructed and patient experiences difficulty in flushing C02 from the
lungs and airway. This results in a gradual increase in the maximum
tracheal C02 level during expiration in obstructive hypopnea, as
illustrated in FIG. 8.


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FIG. 9 illustrates an example of obstructive apnea. The
markedly increased sinusoidal tracheal pressure curve indicates that
the patient is trying to breathe, but the flat tracheal air flow line
indicates that an airway obstruction is preventing airflow from the
mouth or nose into the chest. Tracheal pressure also shows a
generally upward trend from baseline during the period of obstructive
sleep apnea. This increased tracheal pressure is caused by the in-
flow of gas through the transtracheal catheter 10 that is prevented
from escaping due to transient obstruction of the patient's upper
airway. Likewise, blood oxygen saturation decreases with the
obstructive apnea and improves when the obstructive apnea resolves.
Tracheal C02 shows a similar generally upward trend from baseline
during the period of obstructive sleep apnea due to the accumulation
of C02 from the lungs.
In contrast, FIG. 10 depicts an example of central apnea which
might be caused by a defect in the patient's brain or central nervous
system. Both the tracheal pressure and air flow lines are flat,
indicating that the patient is not attempting to breathe during this
period. There is no increase in tracheal pressure because gas
delivered by the transtracheal catheter 10 can freely escape through
the patient's upper airway. As in the other two graphs, blood oxygen
saturation decreases with the central apnea and improves when the
apnea resolves. Tracheal C02 becomes essentially flat with a gradual
upward slope during the period of central apnea.
It should be noted that the present invention can be applied to
other purposes beyond diagnosis of sleep disorders as described
above. For example, the present system can be employed to monitor
the patient's compliance in using transtracheal augmented ventilation
therapy. In addition, the present system can be used to optimize the
flow rate in transtracheal augmented ventilation therapy to minimize
episodes of obstructive sleep apnea and hypopnea. Finally, the


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present system can be used to optimize breathing during sleep with
respiratory disorders such as COPD and chest wall and/or neuro-
muscular disease.
The above disclosure sets forth a number of embodiments of
the present invention. Other arrangements or embodiments, not
precisely set forth, could be practiced under the teachings of the
present invention and as set forth in the following claims.

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Administrative Status , Maintenance Fee  and Payment History  should be consulted.

Administrative Status

Title Date
Forecasted Issue Date 2006-02-21
(86) PCT Filing Date 1998-10-15
(87) PCT Publication Date 1999-04-29
(85) National Entry 2000-04-04
Examination Requested 2000-05-17
(45) Issued 2006-02-21
Deemed Expired 2012-10-15

Abandonment History

Abandonment Date Reason Reinstatement Date
2003-11-27 R30(2) - Failure to Respond 2004-11-25
2004-10-15 FAILURE TO PAY APPLICATION MAINTENANCE FEE 2004-11-25

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Application Fee $300.00 2000-04-04
Request for Examination $400.00 2000-05-17
Maintenance Fee - Application - New Act 2 2000-10-16 $100.00 2000-09-08
Maintenance Fee - Application - New Act 3 2001-10-15 $100.00 2001-10-04
Maintenance Fee - Application - New Act 4 2002-10-15 $100.00 2002-10-08
Maintenance Fee - Application - New Act 5 2003-10-15 $150.00 2003-10-03
Reinstatement - failure to respond to examiners report $200.00 2004-11-25
Reinstatement: Failure to Pay Application Maintenance Fees $200.00 2004-11-25
Maintenance Fee - Application - New Act 6 2004-10-15 $200.00 2004-11-25
Registration of a document - section 124 $100.00 2005-04-29
Maintenance Fee - Application - New Act 7 2005-10-17 $200.00 2005-09-09
Final Fee $300.00 2005-12-09
Maintenance Fee - Patent - New Act 8 2006-10-16 $200.00 2006-09-25
Maintenance Fee - Patent - New Act 9 2007-10-15 $200.00 2007-09-28
Maintenance Fee - Patent - New Act 10 2008-10-15 $250.00 2008-10-06
Maintenance Fee - Patent - New Act 11 2009-10-15 $250.00 2009-10-05
Maintenance Fee - Patent - New Act 12 2010-10-15 $250.00 2010-10-06
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
CS MEDICAL, INC.
Past Owners on Record
CHRISTOPHER, KENT L.
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Representative Drawing 2000-06-06 1 11
Claims 2000-04-05 5 160
Abstract 2000-04-04 1 71
Description 2000-04-04 19 787
Claims 2000-04-04 5 160
Drawings 2000-04-04 8 169
Cover Page 2000-06-06 2 89
Description 2004-11-25 19 782
Claims 2004-11-25 5 156
Representative Drawing 2006-01-19 1 12
Cover Page 2006-01-19 1 54
Assignment 2000-04-04 3 85
PCT 2000-04-04 5 183
Prosecution-Amendment 2000-04-04 1 19
Prosecution-Amendment 2000-04-04 7 203
Prosecution-Amendment 2000-05-17 1 23
PCT 1999-07-15 3 104
Prosecution-Amendment 2003-05-27 3 144
Assignment 2005-04-29 7 312
Prosecution-Amendment 2004-11-25 7 322
Prosecution-Amendment 2005-01-10 1 38
Correspondence 2005-12-09 1 22